A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis

NCT01292187 | Completed Phase 2 Results

• 1 other identifier: TAR-01-201
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 10

Brief Summary

The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.

Conditions

Osteopenia

Keywords

Osteoporosis; Osteopenia; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Salmon calcitonin; Calcitonin

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.

  Baseline, Week 54

Secondary Outcomes (1)

• Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.

  Baseline, Week 54

Study Arms (2)

Oral calcitonin at dinner-or bedtime

EXPERIMENTAL

Intervention: Oral calcitonin at dinnertime or oral calcitonin at bedtime. Postmenopausal subjects with osteopenia were treated for one year (also with vitamin D and calcium supplements) to determine if oral calcitonin tablets would prevent the loss of bone mineral density compared with placebo. Randomization to active or placebo was done 2:1. After randomization, further randomization was done to divide each arm into two groups, one in which dosing was at dinnertime and the other in which dosing was at bedtime to determine if food affected efficacy or safety.

Drug: Oral calcitonin at dinnertime; Drug: Oral calcitonin at bedtime

Oral placebo at dinner- or bedtime

EXPERIMENTAL

Intervention: oral placebo at dinnertime or oral placebo at bedtime

Drug: Oral placebo at dinnertime; Drug: Oral placebo at bedtime

Interventions

Oral calcitonin at dinnertime DRUG

Oral calcitonin at dinnertime.

Also known as: Oral rsCT

Oral calcitonin at dinner-or bedtime

Oral placebo at dinnertime DRUG

Oral placebo at dinnertime.

Also known as: Placebo

Oral placebo at dinner- or bedtime

Oral calcitonin at bedtime DRUG

Oral calcitonin at bedtime

Also known as: Oral rsCT

Oral calcitonin at dinner-or bedtime

Oral placebo at bedtime DRUG

Oral placebo at bedtime

Also known as: Placebo

Oral placebo at dinner- or bedtime

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and at least 45 years of age.
• Must have undergone the onset of spontaneous or surgical menopause more than 5 years prior to entry. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea. Surgical menopause is defined as ≥ 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
• Serum follicle-stimulating hormone (FSH) levels must be ≥ 30 mIU/mL.
• A body mass index (BMI) of not greater than 35 (BMI
• =weight \[kg\]/height\[m\]2).
• Bone mineral density (BMD) T-score between -1.0 and - 2.5 at the total hip, femoral neck, trochanter, or lumbar spine.
• Additional risk factors such that the 10 year risk of a major osteoporotic fracture or hip fracture risk is at least as great as a 65-year-old woman of the same race and BMI of 25 kg/m2 as determined by the FRAX algorithm .
• No clinically significant abnormal findings in the medical history or physical exam that would preclude participation in the investigator's opinion.
• No clinically significant abnormal laboratory values at the screening assessment.
• Subjects must give written informed consent after reading the Subject Information and Consent Form and having had the opportunity to discuss the study with the investigator.

You may not qualify if:

• History of an osteoporotic fracture, defined as a fracture at the wrist, hip, or humerus occurring from a fall at standing height or less.
• BMD T-Score at any site ≤ -2.5.
• Current treatment (or within 3 months prior to randomization) with hormone replacement therapy.
• History of metabolic and other bone diseases, including osteogenesis imperfecta, osteomalacia, and Paget's disease.
• Vitamin D insufficiency defined as a 25 hydroxyvitamin D level \< 20 ng/mL (50 nmol/L).
• Prior use of calcitonin, ever.
• Prior use of any bisphosphonate, ever.
• Prior use of denosumab, fluoride, or strontium, ever.
• Prior use of parathyroid hormone analogs, ever.
• Any condition or disease that may interfere with the ability to have a dual energy x-ray absorptiometry (DXA) scan or to evaluate a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, bilateral hip replacements.
• Use of anabolic steroids or androgens within 6 months preceding randomization.
• Use of estrogen or estrogen-related drugs (including selective estrogen receptor molecules), for example, tamoxifen, tibolone, or raloxifene within 3 months preceding randomization.
• Chronic systemic treatment with glucocorticoids.
• Clinically relevant abnormal history, physical findings, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the subject.
• Presence of acute or chronic illness or history of chronic illness which, in the judgment of the investigator, makes participation in the study medically inappropriate.

Sponsors & Collaborators

• Tarsa Therapeutics, Inc.: lead

Study Sites (10)

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Bethesda Health Research

Bethesda, Maryland, 20817, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01610, United States

Location

Michigan Bone and Mineral Clinic

Detroit, Michigan, 48236, United States

Location

The Osteoporosis Center at St. Luke's Hospital

Chesterfield, Missouri, 63107, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

University of Pittsburgh - Department of Neurology

Pittsburgh, Pennsylvania, 15213, United States

Location

Puget Sound Osteoporosis Center

Seattle, Washington, 98144, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705, United States

Location

Related Links

• Related Info.

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. David Krause, Chief Medical Officer
• Organization: Tarsa Therapeutics, Inc.

dkrause@tarsatherapeutics.com

1-267-273-7940

Study Officials

• David S. Krause, MD

  Chief Medical Officer - Tarsa Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2014-09

Locations

US (10)